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NCT Number: NCT06459141

The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery

The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone cancer surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Min Yan, Doctor

CONTACT

[email protected]

15888210247

Min Yan, Doctor

PRINCIPAL_INVESTIGATOR

About this study

Bone tumor surgery is associated with a significant risk of intraoperative blood loss and transfusion, with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell. The increase in allogeneic blood transfusion volume is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.

Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. It is of great importance to explore the efficacy of ANH in bone cancer surgery patients.

Bone cancer surgery is an ideal setting to evaluate the efficacy of ANH, as the procedure is associated with high blood loss and infusion. The 'Hemodilution on intraoperative Allogeneic Transfusion' (HEAL) trial has been designed as a randomized, controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 to 75 years;
  • undergoing elective bone tumor resection surgery;
  • preoperative hemoglobin ≥11 g/dL;

Exclusion criteria

  • using a tourniquet;
  • palliative operation or minimally invasive surgery;
  • BMI<18.5 or >30Kg/m^2;
  • international normalized ratio (INR) >1.5 or platelet count <100 × 10^9/L;
  • cardiopulmonary insufficiency;
  • hepatic and renal dysfunction;
  • active infectious disease;
  • allergy to succinyl gelatin;
  • pregnancy;
  • declined participation in the study or declined blood transfusion

Treatment and study plan

Acute Normovolemic Hemodilution

Procedure

The ANH was conducted with more than 8 ml/kg of whole blood drawn from an internal jugular introducer by gravity and collected into standard sterile blood storage bags containing citrate phosphate-dextrose anticoagulant. The allowable blood loss was capped according to the preoperative hemoglobin, estimated blood volume, and the target hemoglobin (10 g/dL). The collected blood was simultaneously replaced by an equal volume of succinyl gelatin solution via at least one large bore peripheralvenous catheter to maintain hemodynamic stability.

Primary outcomes

  1. Intraoperative allogeneic red blood cell transfusion volume

    Time frame: From the beginning to the end of the surgery

    The volume of allogeneic red blood cell transfusions during the intraoperative period.

    Between-group comparisons were performed using student t tests for normally distributed data, and Wilcoxon rank-sum tests otherwise.

Secondary outcomes

  1. The rate of perioperative transfusion of allogeneic blood products

    Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first

    This includes blood products such as plasma and platelets, erythrocytes

  2. The blood loss during the perioperative period

    Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first

    The volume of blood loss

  3. The volume of fluid administration during the intraoperative period

    Time frame: From the beginning to the end of the surgery

    This includes intraoperative crystalloid infusion volume and intraoperative colliod infusion volume

  4. The coagulation function tests during the perioperative period

    Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first

    This includes thromboelastography result

  5. The intraoperative hemodynamic indexes

    Time frame: From the beginning to the end of the surgery

    This includes stroke volume variation

  6. Perioperative embolic events

    Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first

    This includes thrombosis and embolism

  7. Perioperative pulmonary infection

    Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first

    Diagnose according to radiologic examination, sign and symptom

  8. Perioperative wound infection

    Time frame: From the start of surgery to discharge or the 7th day following the operation, which comes first

    Diagnose according to sign, symptom, etc

  9. Length of stay in hospital

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 14, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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